OBPM_COYOTE2024 Physiological Data Recording With the Calibration-free Optical Aktiia G2C Device at Fingertip and Wrist, Alongside the Aktiia Oscillometric Cuff
Recruiting · NCT06698536 · Interventional (participants receive a specific treatment) · Lead sponsor: Aktiia SA
View the official record on ClinicalTrials.gov →Interventions studied
Aktiia G2C
What this trial is about
The present study, OBPM\_COYOTE2024, with N = 255 participants minimum over 1 visit (lasting \~15min), has been designed to collect raw optical data with Aktiia.product-G2C Clinical investigational device together with Aktiia G2 Bracelet and Aktiia Init I1 oscillometric cuff within a cohort of subjects characterized by a wide variety of phenotypes. The resulting dataset will support research and development activities conducted by AKTIIA SA out of the study context.
Who can take part
Age range
21 Years to 85 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Subjects aged 21 to 85yo
- Subjects or witnesses fluent in written and spoken French
- Subjects agreeing to attend the study visit and follow study procedures
- Subjects that have signed the informed consent form.
Exclusion criteria
- Amputated index fingers
- Damaged/injured skin at index fingers
- Damaged/injured skin at wrists
- Subjects with tachycardia (heart rate at rest \> 120bpm)
- Subjects with atrial fibrillation
- Subjects with diabetes
- Subjects with marked renal dysfunctions (eGFR \< 30mL/min/1.73 m2)
- Subjects with untreated hyper-/hypothyroidism
- Subjects with pheochromocytoma
- Subjects with Raynaud's disease
- Subjects with an arteriovenous fistula
- Women in known pregnancy
- History of polyneuropathy
Where it is running
1 location listed.
- CHUV Service de Néphrologie et d'Hypertension - Lausanne, Switzerland